In a recent house editorial, the New York Times urges the Food and Drug Administration to “say, unequivocally, that the agency’s approval of and regulatory decisions around prescription drugs, including abortion pills, pre-empt any state-level regulations or statutes.” The purported effect of such a declaration would be to make chemical abortion lawful in states that have laws against abortion.
Never mind that this is the same NYT editorial board that has condemned FDA preemption as a “perverse legal doctrine” and celebrated a Supreme Court decision that “demolished the notion that federal regulatory rulings automatically pre-empt the states from enforcing even tougher standards on drugs.” Far more significant is that NYT’s new abortion-driven version of absolute FDA preemption is absurd.
NYT claims that Attorney General Merrick Garland, in his statement in response to the Dobbs ruling, asserted that states may not ban the drugs used in chemical abortion “based on disagreement with the F.D.A.’s expert judgment.” But NYT clipped Garland’s quote to distort its meaning. In a carefully couched statement, what Garland actually said was: “States may not ban Mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.”
A state that bans mifepristone because it is used to cause abortion is not disagreeing with the FDA’s judgment about the “safety and efficacy” of mifepristone for the mother seeking abortion. So Garland’s statement (whether or not it’s right) provides no support for NYT’s audacious preemption claim.
Supreme Court precedent squarely contradicts NYT’s vision of absolute FDA preemption. In the 2009 ruling in Wyeth v. Levine that NYT celebrated, the Court ruled that FDA approval of a drug and its labeling did not foreclose tort claims under state law for inadequate failure to warn. The position of the three dissenters in that case is rooted in what they saw as the direct conflict between the FDA’s labeling regime and the state tort claims, and thus provides zero basis for NYT’s extreme position.
The idea that FDA approval of mifepristone establishes some sort of imperative federal policy that overrides state laws is also impossible to reconcile with the fact that federal law criminalizes—and indeed subjects to massive RICO penalties—sending mifepristone by mail for the purpose of abortion. Repeal by implication is generally disfavored, and it would be especially odd to think that an agency’s action would repeal a federal law. As the Biden administration itself has recently emphasized in the analogous context of postal-service restrictions on mailing FDA-approved e-cigarettes:
Of course, it is possible for multiple Federal authorities to apply concurrently. FDA authorization of a cigarette for introduction or delivery into interstate commerce does not absolve an actor from other Federal requirements that govern the manufacture and distribution of cigarettes and other covered products: Rather, all overlapping requirements must be complied with in order to offer the product in interstate commerce. [Emphasis added.]
A lesser point: Although you wouldn’t know it from NYT’s editorial, the FDA has not approved the second drug used in the abortion-drug regimen, misoprostol, for that use. It instead has approved misoprostol only for the prevention and treatment of gastric ulcers in patients taking non-steroidal anti-inflammatory drugs. So NYT is calling for sweeping FDA preemption of state abortion laws based on an abortion-drug regimen that the FDA as of now hasn’t in fact approved.
What’s more, a state’s general criminal prohibition can apply to the use of FDA-approved drugs to violate that prohibition, even if a state doesn’t ban those drugs outright. Assume that the FDA approved a drug for use in physician-assisted suicide. Why would anyone imagine that FDA approval overrode state laws barring physician-assisted suicide? Why should it be any different here?